BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIBOND XTR

    MDR report key: 3767407 · Received April 23, 2014

    Report

    Report Number
    2024312-2014-00261
    Event Type
    Injury
    Date Received
    April 23, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 27, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    KLE
    PMA / PMN Number
    K101423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT INFORMATION WITH REGARD TO GENDER, AGE AND WEIGHT WAS NOT PROVIDED. THE PATIENT HAD SWALLOWED THEIR CROWN. A NEW CROWN WAS MADE AND CEMENTED ON (B)(6) 2014 USING A DIFFERENT PRODUCT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT WAS NOT RETURNED; THEREFORE, AN 'ADHESIVE STRENGTH' TEST OF THE RETAIN SAMPLE OF OPTIBOND XTR PRIMER FOR LOT NUMBER 5063121 WAS PERFORMED, YIELDING RESULTS WITHIN SPECIFICATIONS. THE DHR REVIEW REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO THIS COMPLAINT. THE PRODUCT WAS NOT RETURNED FOR OPTIBOND XTR ADHESIVE AND THE LOT NUMBER PROVIDED WAS INVALID; THEREFORE, NO EVALUATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT A PATIENT HAD EXPERIENCED THE LOSS OF A RESTORATION AFTER PLACEMENT WITH THE OPTIBOND XTR PRODUCTS AND NX3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247431 OPTIBOND XTR TOOTH BONDING RESIN KLE KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R NX3